Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Proposed Rules 58157 

1Statement of Commissioner Caroline D. Pham 

on Conditional Order of SEF Registration, U.S. 

Commodity Futures Trading Commission (July 20, 

2022), https://www.cftc.gov/PressRoom/ 

SpeechesTestimony/phamstatement072022. 

2Core Principles and Other Requirements for 

Swap Execution Facilities, 76 FR 1213, 1214 (Jan. 

7, 2011) (codified at 17 CFR part 37). 

3See 17 CFR 37.6(b) (‘‘The confirmation of all 

terms of the transaction shall take place at the same 

time as execution.’’). 

4 Id. 

5See, e.g., NAL No. 17–17, Re: Extension of NoAction Relief for Swap Execution Facility 

Confirmation and Recordkeeping Requirements 

under Commodity Futures Trading Commission 

Regulations 37.6(b), 37.1000, 37.1001, 45.2, and 

45.3(a) (Mar. 24, 2017). 

develop data collection protocols and 

standards for machine readability. Other 

federal financial regulators will push this 

requirement to its registrants and supervised 

entities to collect, maintain, and submit data 

pursuant to these data transparency protocols 

and standards. This will impact registrants in 

our space that are dual registered with those 

financial regulators, and who will need to 

comply with those protocols and standards. 

I look forward to hearing from members of 

industry, investor and consumer advocates, 

academics, and other stakeholders on these 

questions. I thank the staff for their work on 

this issue. 

Appendix 5—Statement of Commissioner 

Caroline D. Pham 

I support the Notice of Proposed 

Rulemaking on Swap Confirmation 

Requirements for Swap Execution Facilities 

(SEF Confirmation Proposal) because the 

Commission is finally fixing unworkable 

rules that have defied the reality of market 

structure, legal documentation, and 

operational processes since they were first 

issued in 2013. I would like to thank Roger 

Smith, Nora Flood, and Vince McGonagle in 

the Division of Market Oversight for their 

work on the SEF Confirmation Proposal. 

As I previously stated, the Commission 

must take action to fix unworkable rules by 

codifying ‘‘perpetual’’ no-action relief 

through notice-and-comment rulemaking as 

required by the Administrative Procedure 

Act.1 I am pleased that we are doing so today. 

The Dodd-Frank Act amended the 

Commodity Exchange Act (CEA) to establish 

the SEF regulatory framework in order to 

reduce risk, promote transparency, and 

enhance market integrity for over-the-counter 

(OTC) derivatives.2 Following that mandate, 

the CFTC implemented Part 37, which 

requires, among other things, that SEFs 

provide written final confirmation for 

uncleared swaps at the time of execution.3

Moreover, Rule 37.6(b) requires that SEFs 

provide each counterparty ‘‘a written record 

of all of the terms of the transaction which 

shall legally supersede any previous 

agreement and serve as a confirmation of the 

transaction.’’ Contrary to its intent, this 

requirement actually undermines legal 

certainty by potentially voiding carefully 

negotiated and highly technical and complex 

legal agreements.4 These provisions, while 

well-intentioned, have proven impracticable 

(if not impossible) for both SEFs and market 

participants. In fact, the requirement to 

provide SEF confirmation at the time of 

execution is temporally impossible for block 

trades, which are executed away from the 

SEF and then submitted to the SEF 

afterwards. 

After hearing from the public, CFTC staff 

provided no-action relief in 2014 that has 

been extended repeatedly in order to provide 

a practical solution that could be 

implemented and would still support the 

CFTC’s public and regulatory transparency 

requirements. For example, the no-action 

relief provided that SEFs could incorporate 

prior agreements to a transaction by 

reference, instead of receiving hundreds of 

thousands of pages of legal agreements, such 

as bilateral counterparty swap trading 

relationship documentation, and then 

attaching hundreds of pages to SEF 

confirmations.5 This requirement was 

unworkable in light of Part 23 rules for swap 

dealers, and for a SEF to collect such legal 

documentation from swap counterparties and 

then to maintain it continuously on an 

ongoing basis (since these bilateral 

agreements are occasionally revised), turns 

SEFs into giant legal document repositories 

of questionable benefit. 

Once CFTC staff realized the unrealistic 

nature of these SEF confirmation 

requirements, I believe the staff very 

prudently issued no-action relief. And I 

believe that this was an appropriate exercise 

of no-action relief because in the rush to 

implement the Dodd-Frank Act, the 

Commission did not always get it right. 

When we don’t get it right, it is incumbent 

upon the Commission to acknowledge 

technical and operational issues and fix 

them. I look forward to public comment, 

particularly whether this proposal 

sufficiently fixes the unworkable aspects of 

our existing rules. Thank you. 

[FR Doc. 2023–17747 Filed 8–24–23; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 161 

[Docket No. FDA–2016–P–0147] 

RIN 0910–AI74 

Fish and Shellfish; Canned Tuna 

Standard of Identity and Standard of 

Fill of Container 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

proposing to amend the standard of 

identity and standard of fill of container 

for canned tuna. This action partially 

responds to a citizen petition submitted 

by Bumble Bee Foods, LLC, StarKist Co., 

and Tri Union Seafoods, LLC (doing 

business as Chicken of the Sea 

International). We tentatively conclude 

that this action, if finalized, will 

promote honesty and fair dealing in the 

interest of consumers. 

DATES: Either electronic or written 

comments on the proposed rule must be 

submitted by November 24, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 24, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, we will post your comment, as 

well as any attachments, except for 


ddrumheller on DSK120RN23PROD with PROPOSALS1
58158 Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Proposed Rules 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–P–0147 for ‘‘Fish and Shellfish; 

Canned Tuna Standard of Identity and 

Standard of Fill of Container.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Shemansky, Center for Food 

Safety and Applied Nutrition (HFS– 

820), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740, 240–402–2371, or Holli Kubicki, 

Center for Food Safety and Applied 

Nutrition, Office of Regulations and 

Policy (HFS–024), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose and Coverage of the Proposed 

Rule 

B. Legal Authority 

C. Costs and Benefits 

II. Background 

A. Need for the Regulation—Citizen 

Petition and Temporary Marketing 

Permits 

B. FDA’s Food Standards Modernization 

C. Incorporation by Reference 

III. Legal Authority 

IV. Description of the Proposed Rule 

A. Proposed Amendments to the Standard 

of Fill of Container 

B. Proposed Amendments to the Standard 

of Identity 

C. Proposed Update of Incorporation by 

Reference 

D. Proposed Additional Revisions 

V. Proposed Effective and Compliance Dates 

VI. Request for Information 

VII. Preliminary Economic Analysis of 

Impacts 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. References 

I. Executive Summary 

A. Purpose and Coverage of the 

Proposed Rule 

FDA is proposing to revise the canned 

tuna standard of identity and standard 

of fill of container established at 

§ 161.190 (21 CFR 161.190). The 

proposed rule, if finalized, will 

modernize and update these food 

standards and is in partial response to 

a citizen petition submitted by Bumble 

Bee Foods, LLC, StarKist Co., and Tri 

Union Seafoods, LLC (doing business as 

(dba) Chicken of the Sea International) 

(the petitioners). The proposed rule 

would: 

• replace the pressed cake weight 

method with the drained weight method 

to determine the standard fill of 

container (see proposed 

§ 161.190(a)(3)(ii) and (iii), (a)(7), and 

(c)); 

• revise the introductory text in 

§ 161.190(a)(5) thereby clarifying that 

use of a packing medium is optional; 

• remove provisions for specific 

flavorings and spices (i.e., monosodium 

glutamate currently in 

§ 161.190(a)(6)(ii), spices or spice oils or 

spice extracts currently in 

§ 161.190(a)(6)(iv), garlic currently in 

§ 161.190(a)(6)(vi), and lemon flavoring 

currently in § 161.190(a)(6)(vii)), which 

are covered under § 101.22(a) (21 CFR 

101.22(a)), to avoid redundancy; 

• revise § 161.190(a)(6)(ii) to allow 

use of safe and suitable optional 

ingredients in accordance with § 101.22, 

and remove the discussion of safe and 

suitable carriers, solubilizing, or 

dispersing ingredients that may be used 

in combination with a flavoring or spice 

ingredient currently in 

§ 161.190(a)(6)(vii); 

• revise § 161.190(a)(1) to move the 

optional ingredient of sodium acid 

pyrophosphate to proposed 

§ 161.190(a)(6)(v) and revise 

§ 161.190(a)(8)(vii) regarding the 

labeling of canned tuna products 

containing sodium acid pyrophosphate 

to update the cross-reference from 

paragraph (a)(1) to paragraph (a)(6)(v); 

• revise the upper and lower limits of 

vegetable extractives under 

§ 161.190(a)(6)(iii) pertaining to amount 

of vegetable broth allowed to be used as 

an optional ingredient; 

• amend § 161.190(a)(8)(vi) for clarity 

and consistency with other label 

declaration provisions in the Code of 

Federal Regulations (CFR); 

• add a provision at § 161.190(a)(8)(x) 

for clarity and consistency with food 

standards in 21 CFR parts 131 through 

169, which include a similar provision 

for label declaration information; 

• revise § 161.190(a)(7) to update the 

method for determining the Munsell 

value and remove the incorporation by 

reference text regarding the Journal of 

the Optical Society of America (in 

current § 161.190(a)(7)(iii)); 

• add paragraph (d) to § 161.190 to 

update the incorporation by reference 

information (currently found in 

§ 161.190(a)(7)); and 

• revise language throughout the 

section to improve clarity and 

readability. 

B. Legal Authority 

We are issuing this proposed rule 

under section 401 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 341), which grants FDA the 

authority to establish a reasonable 

definition and standard of identity, a 

reasonable standard of quality, or 

reasonable standards of fill of container 

if such actions will promote honesty 

and fair dealing in the interest of 

consumers. There are already standards 

of identity and fill of container in place 

for canned tuna (§ 161.190(a) and (c), 

respectively). We tentatively conclude 

that revising these food standards will 

promote honesty and fair dealing in the 

interest of consumers. Allowing for 


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more flexibility and for the use of 

modern methods in the standards will 

allow for production of a wider range of 

products to meet consumer tastes and 

preferences. 

C. Costs and Benefits 

We estimate benefits of the proposed 

rule, if finalized. We estimate ongoing 

annual cost savings ranging from 

approximately $4 million to $15.9 

million at a 3 percent discount rate, and 

approximately $3.9 million to $15.8 

million at a 7 percent discount rate. Our 

primary annualized estimates are 

approximately $7.9 million at both the 

3 percent and 7 percent discount rates. 

The primary estimate of the present 

value of total cost savings in the 10 

years following any final rule that may 

be issued based on the proposed rule is 

$67.6 million at a 3 percent rate of 

discount and $55.4 million at a 7 

percent rate of discount. Manufacturers 

and consumers may benefit from other 

provisions of the proposed rule, if 

finalized, but these impacts are harder 

to quantify. 

The costs of the proposed rule, if 

finalized, are associated with costs to 

industry for reading and understanding 

the rule, training employees on new 

requirements, and the purchase of new 

equipment. These are one-time costs 

that industry incurs immediately after 

any final rule that may be issued based 

on this proposed rule passes its 

compliance date. When annualized over 

a period of 10 years, we estimate these 

costs range from approximately $3,800 

to $6,000 at a 3 percent discount rate, 

and approximately $4,500 to $7,100 at 

a 7 percent discount rate. Our primary 

annualized estimates are approximately 

$4,900 at a 3 percent discount rate and 

$5,800 at a 7 percent discount rate. The 

primary estimate of total costs in the 10 

years following any final rule that may 

be issued based on this proposed rule is 

$41,600 at a 3 percent discount rate and 

$40,600 at a 7 percent discount rate. 

II. Background 

A. Need for the Regulation—Citizen 

Petition and Temporary Marketing 

Permits 

Bumble Bee Foods, LLC, StarKist Co., 

and Tri Union Seafoods, LLC (dba 

Chicken of the Sea) submitted a citizen 

petition (FDA–2016–P–0147) requesting 

that we amend § 161.190 to: 

• base the standard of fill of container 

on the product’s drained weight rather 

than the pressed cake weight; 

• require that the net contents 

declaration include both the net weight 

and drained weight; 

• provide that use of a packing 

medium is optional; 

• permit the use of any flavoring; 

• limit the amount of vegetable broth 

that may be added as a flavoring based 

on the dry weight of the vegetable 

extractives; 

• provide that a label statement about 

added salt is optional; and 

• specify that canned tuna is packed 

in hermetically sealed rigid metal cans 

to clarify that pouch tuna products are 

not covered by the standard of identity. 

(See Citizen Petition from Steven 

Mavity, Senior Vice President, 

Technical Services & Corporate Quality, 

Bumble Bee Foods, LLC, Nabil Salib, 

Vice President of Operations, StarKist 

Co., and John DeBeer, Vice President, 

Tri-Union Seafoods, LLC (dba Chicken 

of the Sea International), to Division of 

Dockets Management, Food and Drug 

Administration, dated September 3, 

2015 (‘‘petition’’) at page 1.) The 

proposed rule would revise the canned 

tuna standard of fill of container and 

standard of identity in partial response 

to the petition. 

In addition to submitting a citizen 

petition, the petitioners submitted 

applications for temporary marketing 

permits (TMP) to market test products 

(designated as ‘‘canned tuna’’ products) 

that deviate from the requirements in 

§ 161.190. We issued the temporary 

permits to each applicant in accordance 

with 21 CFR 130.17 (see 79 FR 35362, 

June 20, 2014). The temporary permits 

covered limited interstate marketing 

tests of products identified as ‘‘canned 

tuna.’’ These test products deviated 

from § 161.190 in that they did not meet 

the standard of fill of container and 

were not labeled with the statement 

‘‘Below Standard in Fill’’ as required in 

§ 161.190(c)(4) and 21 CFR 130.14(b). 

The TMPs allowed applicants to test 

market canned tuna products using a 

standard fill of container based on the 

drained weight rather than the pressed 

cake weight. The TMPs also allowed 

applicants to provide a net quantity of 

contents declaration that includes both 

the net and drained weight. In the 

Federal Register of March 7, 2016 (81 

FR 11813), we announced an extension 

of the temporary permits. The extension 

allowed the applicants to continue to 

measure consumer acceptance of the 

products and assess the commercial 

feasibility of the products, in support of 

the petition to amend § 161.190. The 

new expiration date for the permits is 

either the effective date of a final rule 

amending § 161.190 that may result 

from the petition or 30 days after denial 

of the petition. All other conditions and 

terms of the permits remained the same 

(see 81 FR 11813). In the March 7, 2016, 

notice, we invited other interested 

parties to participate in the market test 

(id.). To date, FDA has approved several 

firms to participate in the market test. In 

the Federal Register of March 5, 2021 

(86 FR 12954), we published a notice 

amending StarKist Co.’s temporary 

permit to add three manufacturing 

locations and to increase the amount of 

test product. More recently, in the 

Federal Register of December 28, 2021 

(86 FR 73789), we published a notice 

adding a manufacturing location for 

both Bumble Bee Foods, LLC and 

StarKist Co. and to increase the amount 

of test product that could be marketed 

by StarKist Co. We also published a 

notice in the Federal Register of 

December 21, 2022 (87 FR 78110), 

allowing StarKist Co. to manufacture 

test product at one additional plant. 

These active TMPs for canned tuna 

products allowed applicants to deviate 

from § 161.190 so the standard fill of 

container is based on the drained weight 

method rather than the pressed cake 

weight method. Based on input from the 

industry, we understand that use of the 

pressed weight method is outdated. 

Products using the drained weight 

method appear to have gained consumer 

acceptance since becoming available. 

Our proposed amendments to § 161.190 

will modernize multiple aspects and 

requirements of the standards, including 

allowing use of the drained weight 

method. 

B. FDA’s Food Standards Modernization 

Section 401 of the FD&C Act 

specifically states that standards are 

meant to promote honesty and fair 

dealing in the interest of the consumer. 

Food standards typically set forth 

permitted ingredients, both mandatory 

and optional, and sometimes specify the 

amount or proportion of each 

ingredient. Many food standards also 

designate the method of production. 

Since we established many food 

standards decades ago, various 

stakeholders have expressed concerns 

that many food standards are out of date 

and may impede innovation. The goal in 

updating or modernizing food standards 

is to maintain the basic nature and 

essential characteristics of standardized 

foods, while permitting flexibility for 

more modern methods, technologies, or 

new ingredients, as well as continued 

innovations (see https://www.fda.gov/ 

food/food-labeling-nutrition/standardsidentity-food). We seek to modernize 

food standards in a manner that will: (1) 

protect consumers against economic 

adulteration; (2) maintain the food’s 

basic nature, essential characteristics, 

and nutritional integrity; and (3) 

promote industry innovation and 

provide flexibility to encourage 

manufacturers to produce more healthy 


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58160 Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Proposed Rules 

foods (see 84 FR 45497 at 45499, August 

29, 2019). 

Amending the canned tuna standards 

may help modernize these food 

standards and may provide consumers 

with a wider variety of choices of tuna 

products. Additional choices of tuna 

products could lead to increased 

consumption. The 2020–2025 Dietary 

Guidelines for Americans (Ref. 1 at page 

34) (see also https://

www.dietaryguidelines.gov) notes 

almost 90 percent of Americans do not 

meet the recommendation for seafood 

intake. 

C. Incorporation by Reference 

The proposed rule, if finalized, would 

incorporate by reference Definitions of 

Terms and Explanatory Notes from 

Table 1, Nominal Dimensions of 

Standard Test Sieves (U.S.A. Standard 

Series), in Official Methods of AOAC 

INTERNATIONAL, 22nd Ed. (2023). 

The Office of the Federal Register (OFR) 

has regulations concerning 

incorporation by reference (see 1 CFR 

part 51). These regulations require that, 

for a final rule, Agencies must discuss 

in the preamble to the rule the way in 

which materials that the Agency 

incorporates by reference are reasonably 

available to interested persons, and how 

interested parties can obtain the 

materials. Additionally, the preamble to 

the rule must summarize the material 

(see 1 CFR 51.5(b)). 

In accordance with the OFR’s 

requirements, the discussion in section 

IV.C. of this document summarizes the 

required provisions of the material that 

we propose to incorporate by reference. 

Interested persons may purchase a copy 

of the material from AOAC 

INTERNATIONAL (AOAC), 2275 

Research Blvd., Suite 300, Rockville, 

MD 20850–3250, 1–800–379–2622. You 

may inspect a copy at Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

240–402–7500, between 9 a.m. and 4 

p.m., Monday through Friday. AOAC 

INTERNATIONAL provides access to 

table 1 at https://academic.oup.com/ 

aoac-publications/book/45491/chapter/ 

392327291. 

III. Legal Authority 

We are issuing this proposed rule 

under section 401 of the FD&C Act, 

which grants FDA the authority to 

establish a reasonable definition and 

standard of identity, a reasonable 

standard of quality, or reasonable 

standards of fill of container if such 

actions will promote honesty and fair 

dealing in the interest of consumers. 

Canned tuna is among the foods that 

FDA has standardized under this 

authority (see § 161.190). Standards of 

identity and fill of container were 

established for canned tuna in 1957 (see 

22 FR 892, February 13, 1957). Although 

the standards have been amended 

several times, certain requirements 

appear to be outdated. We tentatively 

conclude that amending these 

requirements in the standards will 

promote honesty and fair dealing in the 

interest of consumers. Allowing for 

more flexibility and for the use of 

modern methods in the standards will 

allow for production of a wider range of 

products to meet consumer tastes and 

preferences. 

IV. Description of the Proposed Rule 

We are proposing to amend our 

canned tuna standard of identity and 

standard of fill of container (§ 161.190). 

The proposed rule would allow industry 

to use the internationally accepted 

drained weight method, further clarify 

the standards, and permit more 

flexibility. The proposed rule also 

would further clarify whether certain 

ingredients are optional within the 

standard of identity. 

A. Proposed Amendments to the 

Standard of Fill of Container 

The current standard of fill of 

container for canned tuna requires that 

the pressed cake weight method be used 

(see § 161.190(c)(1)). The petition 

requested, in part, that the pressed cake 

weight method be replaced with the 

drained weight method (petition at 

pages 1 and 9). 

We agree that the pressed cake weight 

method should be replaced with the 

drained weight method. We do not agree 

with the petitioners’ suggestion to base 

the drained weight method for canned 

tuna products solely on the AOAC 

Official Method 968.30 Canned 

Vegetables: Drained Weight Procedure 

(petition at page 7). This method is 

specific for canned vegetables and 

requires modification for canned tuna. 

We propose to use a drained weight 

method that is based on both the 

drained weight method specified in the 

Codex standard for canned tuna and 

bonito (CODEX STAN 70–1981) (Ref. 2) 

and the AOAC method 968.30 (Ref. 3). 

Although both methods are very similar, 

the Codex standard helps to provide 

necessary details to modify the AOAC 

method 968.30 for canned tuna. 

The proposed rule would delete the 

text in § 161.190(c) ‘‘Fill of container’’ 

and replace it with text on the drained 

weight method. The proposed rule 

would, however, keep the provision 

currently at § 161.190(c)(4) for canned 

tuna that falls below the applicable 

standard of fill of container, but would 

redesignate it as § 161.190(c)(3) to be 

consistent with other proposed changes 

to the standard. The proposed rule also 

would update certain provisions in the 

canned tuna standard of identity to 

reflect the proposed change from the 

pressed cake weight method to the 

drained weight method. Specifically, 

the proposed rule would change the 

specifications for chunk and flake tuna 

in § 161.190(a)(3)(ii) and (iii), 

respectively, so they will be based on 

the ‘‘drained weight of the contents of 

the container’’ instead of the ‘‘pressed 

contents’’ of the container. Additionally, 

the proposed rule would amend 

§ 161.190(a)(7) so that portions of the 

drained product are combined rather 

than starting with a pressed cake. To 

maintain the structure of the standard, 

the proposed rule would redesignate 

other sections of the current standard 

and replace the pressed cake weight 

method with the drained weight method 

in the redesignated paragraphs. 

Specifically, the proposed rule would 

redesignate the determination of free 

flakes in § 161.190(c)(2)(xi) as 

§ 161.190(c)(2)(i) and revise the newly 

designated paragraph (c)(2)(i). The 

proposed rule would redesignate 

determination of particle size from 

§ 161.190(c)(2)(xii) to § 161.190(c)(2)(ii) 

and revise newly designated paragraph 

(c)(2)(ii). The redesignated paragraphs 

in paragraphs (c)(2)(i) and (ii) would be 

revised to incorporate the drained 

weight method. The proposed rule also 

would redesignate the paragraph that 

describes a sieving device used for size 

separation in § 161.190(c)(3)(iv) as 

§ 161.190(c)(2)(iii). 

We are proposing these changes 

because the pressed cake weight method 

is only required in the U.S. canned tuna 

standards and does not align with 

current industry practice in the United 

States. For example, the pressed cake 

weight method relies upon using a 3- 

piece can, but the current industry 

practice is to use a 2-piece can. In 

comparison, the type of packaging is 

irrelevant when using the drained 

weight method. The pressed cake 

weight method relies on more complex 

instrumentation and requires more steps 

than the drained weight method, 

resulting in a more costly procedure 

with a wider margin of error than the 

drained weight method. The pressed 

cake weight method is therefore more 

difficult to perform, more prone to 

human error, and may produce 

inconsistent results compared with the 

drained weight method. The drained 

weight method is used in the 

production of many other foods, both 


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domestically and internationally. FDA 

food standards require the drained 

weight method in production of canned 

fruit cocktail, canned pineapple, canned 

green beans and canned wax beans, 

canned tomatoes, canned mushrooms, 

and canned oysters (see 21 CFR 145.135, 

145.180, 155.120, 155.190, 155.201, and 

161.145, respectively). Compared to the 

pressed cake weight method, the 

drained weight method is easier to 

perform, and produces more consistent 

and reliable results. The drained weight 

method can be performed using a 

balance or a food scale and a sieve or 

strainer. 

The proposed amendments to 

§ 161.190(c) differ from what the 

petition requested because we describe 

the drained weight method for use with 

canned tuna products in the standard. 

The proposed drained weight method is 

based on both the Codex standard for 

canned tuna and bonito (Ref. 2) and the 

AOAC drained weight method for 

canned vegetables (Ref. 3). Both the 

proposed drained weight method and 

the Codex standard contain more details 

than the AOAC drained weight method 

requested in the petition. The Codex 

standard gives clear, easy-to-follow 

instructions that are specific for canned 

tuna products. The proposed drained 

weight method aims for clarity, 

readability, and ease of implementation. 

As a result, the proposed canned tuna 

standard of fill incorporates much of the 

Codex standard, except the units are 

changed to include both the imperial 

system as well as the metric system (for 

example, including temperature ranges 

in both Fahrenheit and Celsius, and 

sieve sizes in inches and centimeters). 

However, we propose to maintain some 

components of the current pressed cake 

weight method, such as the temperature 

range. We are also proposing to 

maintain using the average weight from 

24 cans but modifying it to use the 

average weight from a minimum of 24 

containers to allow manufacturers to 

adjust their sampling amount for larger 

production volumes, if needed. 

Additionally, we disagree with the 

petitioners’ request to limit the standard 

to rigid metal cans (petition at pages 1, 

2, and 10). The proposed drained weight 

method may be used for any type of 

hermetically sealed container (e.g., can, 

pouch, jar), in contrast to the pressed 

cake method, which required the use of 

rigid metal cans to meet the 

requirements. Accordingly, we have not 

proposed any conforming changes to 

limit the standard of identity to rigid 

metal containers in § 161.190(a)(1) as 

the petition requested. In addition, to 

help make clear that hermetically sealed 

containers in which canned tuna is 

packed may include containers other 

than rigid metal cans, we are proposing 

to revise § 161.190(a)(3)(i) to 

consistently refer to ‘‘container’’ or 

‘‘containers’’ rather than ‘‘can’’ or 

‘‘cans.’’ 

Unlike the pressed cake weight 

method, the drained weight method is 

simple enough that a consumer could 

check the amount of tuna at home if 

they wanted to verify the amount of 

tuna in the package. The switch from 

the pressed cake weight method to the 

drained weight method may promote 

honesty and fair dealing in the interest 

of the consumer. 

B. Proposed Amendments to the 

Standard of Identity 

1. Clarification That a Packing Medium 

Is Optional 

The petition requested that we 

provide that the use of a packing 

medium is optional (petition at pages 1 

and 9). Under our current regulations, 

the use of packing media is optional 

(§ 161.190(a)(5)); however, to further 

clarify, the proposed rule would revise 

the introductory paragraph of 

§ 161.190(a)(5) to read ‘‘Optional 

packing media. Canned tuna may be in 

one or more of the following optional 

packing media:’’. We propose to add a 

paragraph heading to help improve 

clarity of the section. We also propose 

a conforming revision to paragraph 

(a)(1) to read, in relevant part, ‘‘. . . 

may be in one or more of the optional 

packing media specified in paragraph 

(a)(5) of this section, . . .’’. 

2. Revocation of the Requirement That 

Canned Tuna Bear a Label Statement 

When Salt Is Used as an Optional 

Ingredient 

Under our current regulations, salt is 

an optional ingredient (see 

§ 161.190(a)(6)(i)). If salt is used as an 

ingredient, the label of canned tuna 

must bear the statement ‘‘seasoned with 

salt’’ (§ 161.190(a)(8)(vi)). Alternatively, 

the label may bear any of the statements 

‘‘salted,’’ ‘‘with added salt,’’ or ‘‘salt 

added’’ if salt is the only seasoning 

ingredient used. The petition requested 

that we make a label statement about 

added salt optional (petition at pages 1 

and 10). 

We agree that a label statement about 

salt should not be mandatory given that 

salt must be declared on the label in the 

ingredient statement (see section 

403(i)(2) of the FD&C Act (21 U.S.C. 

343(i)(2)) and § 101.4 (21 CFR 101.4(a))). 

We also note that salt is not a 

characterizing ingredient that 

differentiates canned tuna varieties such 

as those seasoned with flavorings and 

spices, vegetable broth, or vegetable 

oil(s). Consequently, we propose to 

amend § 161.190(a)(8)(vi) to only apply 

to the characterizing ingredients in 

§ 161.190(a)(6)(ii) through (iv) and not 

to salt. 

In addition, the proposed rule would 

clarify § 161.190(a)(6) so it is easily 

understood that salt is an optional 

ingredient. The proposed rule would 

amend the introductory paragraph in 

§ 161.190(a)(6) to include the heading 

‘‘Optional Ingredients. One or more of 

the following safe and suitable optional 

ingredients may be used:’’. This 

proposed change also would make the 

format in the canned tuna standard 

more consistent with other standards, 

such as the canned Pacific salmon and 

canned wet pack shrimp standards (see 

§§ 161.170 and 161.173, respectively). 

3. Expand Optional Ingredients To 

Allow for Safe and Suitable Flavorings 

and Spices in Accordance With § 101.22 

Our current regulations list 

seasonings and flavorings with which 

canned tuna may be seasoned or 

flavored (§ 161.190(a)(6)). The petition 

requested that FDA permit the use of 

any flavoring (petition at pages 1 and 9). 

We agree that the canned tuna 

standard is restrictive regarding the use 

of flavorings. The proposed rule would 

amend § 161.190(a)(6)(ii) to permit 

flavorings and spices in accordance 

with § 101.22 as optional ingredients. 

The proposed rule would make 

corresponding revisions to 

§ 161.190(a)(1) by changing ‘‘seasonings 

and flavorings’’ to ‘‘safe and suitable 

optional ingredients.’’ To avoid 

redundancy, the proposed rule would 

remove monosodium glutamate 

(currently listed in § 161.190(a)(6)(ii)), 

spices or spice oils or spice extracts 

(currently listed in § 161.190(a)(6)(iv)), 

garlic (currently listed in 

§ 161.190(a)(6)(vi)), and lemon flavoring 

(currently listed in § 161.190(a)(6)(vii)) 

because these ingredients are covered 

under § 101.22 (Foods; labeling of 

spices, flavorings, colorings and 

chemical preservatives). 

The proposed rule would remove 

spices or spice oils or spice extracts 

from § 161.190(a)(6)(iv) and would 

group them with flavorings and spices 

in § 161.190(a)(6)(ii). Spice oils and 

spice extracts would still be permitted 

as optional ingredients in canned tuna 

because they are covered under 

proposed § 161.190(a)(6)(ii). Spice oils 

and spice extracts are covered under 

natural flavorings as defined in 

§ 101.22(a)(3). 

The proposed rule also would remove 

hydrolyzed protein (currently listed in 

§ 161.190(a)(6)(iii)) because hydrolyzed 


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protein is a flavor and a flavor enhancer 

(see § 101.22(h)(7)) and therefore is 

covered under proposed 

§ 161.190(a)(6)(ii). 

The proposed rule would remove the 

text regarding sodium acid 

pyrophosphate currently in 

§ 161.190(a)(1) and move it to proposed 

§ 161.190(a)(6)(v). This revision would 

consolidate the optional ingredients in 

the standard and better clarify that 

sodium acid pyrophosphate is also an 

optional ingredient. The proposed rule 

would also revise § 161.190(a)(8)(vii) 

regarding labeling of canned tuna 

products that contain sodium acid 

pyrophosphate to update the crossreference for the new location of the 

sodium acid phosphate optional 

ingredient provision from paragraph 

(a)(1) to paragraph (a)(6)(v). As for 

lemon flavoring, as stated earlier, the 

proposed rule would remove the lemon 

flavoring paragraph in 

§ 161.190(a)(6)(vii), and it also would 

remove the language specific to lemon 

flavoring in § 161.190(a)(8)(vi) and (viii) 

and renumber the remaining paragraphs 

accordingly. 

To further effectuate the changes 

proposed in § 161.190(a)(6)(ii) through 

(iv), the proposed rule would include 

conforming changes to the label 

declaration provisions in proposed 

§ 161.190(a)(8)(vi). Specifically, we 

propose revising § 161.190(a)(8)(vi) to 

state that ‘‘[i]f the canned tuna contains 

one or more of the optional ingredients 

in paragraphs (a)(6)(ii) through (iv) of 

this section, the label must 

appropriately declare the ingredients by 

the common or usual name in 

accordance with § 101.22. If the 

ingredients designated in paragraph 

(a)(6)(iii) of this section are used, the 

term ‘vegetable broth’ must be 

declared.’’ The proposed rule would 

also add that the label statements 

declare the ingredients by the common 

or usual name ‘‘in accordance with 21 

CFR 101.22’’ for clarity and consistency 

with our other regulations (proposed 

§ 161.190(a)(8)(vi)) (see, for example, 21 

CFR 163.111(c)(3) (Chocolate liquor) 

and 21 CFR 163.124(c) (White 

chocolate)). In addition, the proposed 

rule would add a provision in 

§ 161.190(a)(8)(x) that states that ‘‘Each 

of the ingredients used in the food must 

be declared on the label as required by 

the applicable sections of parts 101 and 

130 of this chapter.’’ The proposed 

revision would be consistent with other 

food standards (see, for example, 21 

CFR 145.175(a)(4)(iv) (Canned pears) 

and 21 CFR 161.145(a)(4) (Canned 

oysters)). 

Use of additional flavor profiles, along 

with the use of more modern methods, 

may help industry in producing canned 

tuna products that better meet evolving 

tastes and consumer preferences. This 

may help encourage tuna consumption 

consistent with the seafood 

recommendations outlined in the 2020– 

2025 Dietary Guidelines for Americans 

(Ref. 1). 

We note that a notice of proposed 

rulemaking, ‘‘Use of Salt Substitutes to 

Reduce the Sodium Content in 

Standardized Foods,’’ proposes 

additional changes that would amend 

§ 161.190(a)(6)(i) to allow the use of salt 

substitutes, if finalized (see 88 FR 

21148, April 10, 2023). Additionally, we 

note that a direct final rule, ‘‘Revocation 

of Uses of Partially Hydrogenated Oil in 

Foods’’ (see 88 FR 53764, August 9, 

2023), and companion notice of 

proposed rulemaking, ‘‘Revocation of 

Uses of Partially Hydrogenated Oil in 

Foods; Companion Document to Direct 

Final Rule’’ (see 88 FR 53827, August 9, 

2023), revised § 161.190(a)(6)(viii) to 

remove partially hydrogenated vegetable 

oil. This proposed rulemaking would 

redesignate § 161.190(a)(6)(viii) as 

§ 161.190(a)(6)(iv) to accommodate 

other proposed changes to 

§ 161.190(a)(6) and proposes minor 

editorial changes to the language in the 

paragraph. 

4. Revise the Upper and Lower Limits 

of Vegetable Extractives for Vegetable 

Broth Used as an Optional Flavoring 

Ingredient 

Our current regulations state that 

canned tuna may be seasoned or 

flavored with vegetable broth in an 

amount not in excess of 5 percent of the 

volume capacity of the container, such 

broth to consist of a minimum of 0.5 

percent by weight of vegetable 

extractives and to be prepared from two 

more of the following vegetables: beans, 

cabbage, carrots, garlic, onions, parsley, 

peas, potatoes, green bell peppers, red 

bell peppers, spinach, and tomatoes (see 

§ 161.190(a)(6)(v)). The petition 

requested, among other things, that we 

revise this paragraph to limit the 

amount of vegetable broth that may be 

added as a flavoring based on the dry 

weight of the vegetable extractives, as 

well as revise the wording to reflect 

current industry practices and 

terminology (petition at pages 1, 3, and 

10). 

We generally agree with the 

petitioners’ suggested rephrasing. 

Vegetable broth is no longer added 

directly to the can; it is added as 

extractives and water, separately. 

Shifting the range of permitted vegetable 

extractives would result in a reduction 

in the concentration of permitted 

vegetable broth in standardized canned 

tuna products. 

We understand that the current upper 

limit of 5 percent vegetable extractives 

is likely not used due to flavor and 

gelling issues. We support lowering the 

upper limit of vegetable extractives to 

2.5 percent as the petition requested 

(petition at page 3). However, we seek 

additional information regarding the 

rationale for the lower limit of 0.025 

percent vegetable extractives requested 

in the petition (id.). The proposed rule 

would revise the upper limit range of 

vegetable extractives to 2.5 percent and 

remove the lower limit of vegetable 

extractives. The petition’s requested 

lower limit of 0.025 percent vegetable 

extractives would add a small amount of 

vegetable extractives, similar to tuna 

packed in water. If a firm adds any 

vegetable extractives, regardless of the 

percentage, the firm must disclose the 

ingredients on the label (§ 101.4). We 

invite comments on the petitioners’ 

request for a lower limit of 0.025 

percent vegetable extractives (petition at 

page 3). 

The proposed rule also would 

redesignate § 161.190(a)(6)(v) as 

§ 161.190(a)(6)(iii) to accommodate 

other proposed changes to paragraph 

(a)(6) regarding optional ingredients. 

5. Revise and Update the Method for 

Color Determination 

The proposed rule would revise and 

update the method for color 

determination in § 161.190(a)(7). 

Currently, the regulation describes use 

of an optical comparator for determining 

the Munsell values for the color 

designations for canned tuna in 

§ 161.190(a)(4). We propose removing 

the portions of § 161.190(a)(7) that are 

specific to the use of an optical 

comparator as this change will 

accommodate the use of electronic color 

meters to determine the Munsell values. 

Electronic color meters are likely faster, 

more widely used, and more objective 

than using an optical comparator. These 

proposed changes would align the level 

of detail for the canned tuna method for 

color determination with other 

regulations that rely on Munsell values 

(see, e.g., Canned tomatoes (21 CFR 

155.190) and Vegetable Juices (21 CFR 

part 156)). 

Additionally, we propose to remove 

the incorporation by reference in 

§ 161.190(a)(7)(iii) of the 1943 report 

regarding the spacing of Munsell colors 

published in the Journal of the Optical 

Society of America. Removing the 1943 

Journal of the Optical Society of 

America reference would be consistent 

with other U.S. food standards, which 

refer to the Munsell value without citing 


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a source or otherwise incorporating an 

article by reference in support. 

C. Proposed Update of Incorporation by 

Reference 

To help with readability of the 

section, we propose to add a new 

paragraph (d) ‘‘Incorporation by 

reference.’’ for the proposed updates to 

the IBR paragraphs in § 161.190(a)(7). 

Currently, § 161.190(a)(7) incorporates 

by reference the ‘‘Official Methods of 

Analysis of the Association of Official 

Analytical Chemists,’’ 13th Edition 

(1980), Table 1, ‘‘Nominal Dimensions 

of Standard Test Sieves (U.S.A. 

Standard Series),’’ under the heading 

‘‘Definitions of Terms and Explanatory 

Notes.’’ We propose to update the 

regulation to refer to the 22nd Edition 

of the same table. Table 1 provides 

information about international and 

USA standard sieve sizes, including 

sieve designations, the nominal sieve 

opening (in inches), and the nominal 

wire diameter (in millimeters) for each 

sieve. 

We propose several updates to the 

contact information for access to the IBR 

materials. Specifically, we propose 

updating the National Archives and 

Records Administration’s (NARA’s) 

contact information by removing the 

phone number, revising the URL, and 

adding an email address. We propose 

adding FDA’s Dockets Management 

Staff contact for information regarding 

the availability of copies of the material 

incorporated by reference in proposed 

§ 161.190(d). We also propose to update 

the address and to add a phone number 

for AOAC INTERNATIONAL. 

These proposed changes will ensure 

that the reference materials are 

accessible, if needed, and in accordance 

with the specified requirements for 

incorporation by reference in the CFR. 

We note that a notice of proposed 

rulemaking, ‘‘Use of Salt Substitutes to 

Reduce the Sodium Content in 

Standardized Foods,’’ proposes a new 

section (§ 161.10) for the incorporation 

by reference information for all of part 

161 (see 88 FR 21148). There is no 

substantive difference between the 

material we propose to incorporate by 

reference in this proposal and the 

proposed material incorporated by 

reference in the salt substitutes 

proposed rule. 

D. Proposed Additional Revisions 

We are proposing additional revisions 

throughout the section to improve the 

clarity and readability of the section and 

to use plain language. For example, we 

are proposing to add paragraph 

headings for paragraphs (a)(1) through 

(8), and we are proposing editorial 

changes to simplify phrasing and to use 

consistent terminology throughout the 

section. 

V. Proposed Effective and Compliance 

Dates 

We propose that any final rule that 

may be issued based on this proposed 

rule become effective 30 days after 

publication of the final rule in the 

Federal Register. The final rule would 

apply to affected products initially 

produced or initially delivered for 

introduction into interstate commerce 

on or after the effective date. We 

propose that the compliance date for 

any final rule that may be issued based 

on this proposed rule be 1 year after 

publication of the final rule in the 

Federal Register. 

VI. Request for Information 

The petition requested that we limit 

the amount of vegetable broth that may 

be added as a flavoring based on the dry 

weight of the vegetable extractives used 

(petition at page 1). The standard of 

identity currently states the vegetable 

extractives are not to exceed 5 percent 

of the volume capacity of the container, 

with a minimum broth consisting of 0.5 

percent by weight of vegetable 

extractives (§ 161.190(a)(6)(v)). The 

petition requested that the dry weight of 

the vegetable extractives in the aqueous 

broth is at least 0.025 percent and not 

more than 2.5 percent of the labeled net 

weight of the container (petition at 

pages 3 and 10). 

The proposed rule would revise the 

upper limit range of vegetable 

extractives to 2.5 percent but remove the 

lower limit of vegetable extractives (see 

proposed § 161.190(a)(6)(iii)). Thus, in 

addition to comments on the proposed 

rule itself, we request comments on 

whether there should be a lower limit of 

vegetable extractives and if so, whether 

the lower limit should be 0.025 percent 

as the petition requested (petition at 

page 3) or another percentage. Please 

provide data to support a lower limit. 

VII. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 14094, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866 Section 3(f)(1) (as amended by 

Executive Order 14094) if they ‘‘have an 

annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator of [the Office of 

Information and Regulatory Affairs 

(OIRA)] for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this proposed rule 

is not a significant regulatory action 

under Executive Order 12866 Section 

3(f)(1). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the proposed rule would not 

significantly increase costs to 

manufacturers, we propose to certify 

that the proposed rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes estimates of anticipated 

impacts, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $177 

million, using the most current (2022) 

Implicit Price Deflator for the Gross 

Domestic Product. This proposed rule 

would not result in an expenditure in 

any year that meets or exceeds this 

amount. 

The proposed rule, if finalized, would 

amend existing requirements for the 

canned tuna standard of identity and 

standard of fill of container. These 

include changes to methods for 

determining the fill of a container, 

expanding the list of optional flavorings 

and spices, and reducing the maximum 

amount of vegetable broth that can be 

used as an ingredient. The proposed 

rule is in partial response to a 2015 

citizen petition submitted by Bumble 

Bee Foods, LLC, StarKist Co., and Tri 

Union Seafoods, LLC (dba Chicken of 

the Sea). 

To estimate costs and benefits 

associated with the proposed rule, we 

assume that the appropriate baseline is 

the state of the world with the current 

standard of identity and standard of fill 


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of container for canned tuna. We then 

compare the likely impacts of the 

proposed rule against this baseline. The 

quantifiable benefits of the proposed 

rule accrue to canned tuna 

manufacturers. These firms benefit from 

switching to a less costly method for 

determining the fill of a container. We 

estimate ongoing annual cost savings 

ranging from approximately $4 million 

to $15.9 million at a 3 percent discount 

rate, and approximately $3.9 million to 

$15.8 million at a 7 percent discount 

rate. Our primary annualized estimates 

are approximately $7.9 million at both 

the 3 percent and 7 percent discount 

rates. The primary estimate of the 

present value of total cost savings in the 

10 years following any final rule that 

may be issued based on the proposed 

rule is $67.6 million at a 3 percent rate 

of discount and $55.4 million at a 7 

percent rate of discount. Manufacturers 

and consumers may benefit from other 

provisions of the proposed rule, if 

finalized, but these impacts are harder 

to quantify. We summarize quantified 

benefits in table 1. 

The costs of the proposed rule, if 

finalized, are associated with costs to 

industry for reading and understanding 

the rule, training employees on new 

requirements, and the purchase of new 

equipment. These are one-time costs 

that industry incurs immediately after 

any final rule that may be issued based 

on the proposed rule passes its 

compliance date. When annualized over 

a period of 10 years, we estimate these 

costs range from approximately $3,800 

to $6,000 at a 3 percent discount rate, 

and approximately $4,500 to $7,100 at 

a 7 percent discount rate. Our primary 

annualized estimates are approximately 

$4,900 at a 3 percent discount rate and 

$5,800 at a 7 percent discount rate. The 

primary estimate of the present value of 

total costs in the 10 years following any 

final rule that may be issued based on 

the proposed rule is $41,600 at a 3 

percent discount rate and $40,600 at a 

7 percent discount rate. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year ............. $7.9 

7.9 

$3.9 

4 

$15.8 

15.9 

2022 

2022 

7 

3 

10 

10 

Annualized Quantified ..................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ....................................................... 

Costs: 

Annualized Monetized $millions/year ............. 0.01 

0.00 

0.00 

0.00 

0.01 

0.01 

2022 

2022 

7 

3 

10 

10 

Annualized Quantified ..................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ....................................................... 

Transfers: 

Federal Annualized Monetized $millions/year ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To .......................................................... From: To: 

Other Annualized Monetized $millions/year ... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

From/To .......................................................... From: To: 

Effects: 

State, Local or Tribal Government: None. 

Small Business: None. 

Wages: None. 

Growth: None. 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule (Ref. 4) and at https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.32(a) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

While FDA tentatively concludes that 

this proposed rule contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required. The previously 

approved collections of information are 


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subject to review by OMB under the 

PRA. The collections of information in 

21 CFR part 101 have been approved 

under OMB control number 0910–0381. 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

proposed rule does not contain policies 

that would have a substantial direct 

effect on one or more Indian Tribes, on 

the relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. FDA 

solicits comments from tribal officials 

on any potential impact on Indian 

Tribes from this proposed action. 

XII. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they are also available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available only at the 

Dockets Management Staff. FDA has 

verified the website addresses, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

* 1. U.S. Department of Agriculture and U.S. 

Department of Health and Human 

Services. ‘‘Dietary Guidelines of 

Americans, 2020–2025,’’ 9th ed. 

* 2. Codex Alimentarius, International Food 

Standards, Codex standard for canned 

tuna and bonito (CODEX STAN 70–1981, 

R (Adopted in 1981. Revised in 1995. 

Amended in 2011, 2013, 2016, 2018.). 

https://www.fao.org/fao-whocodexalimentarius/sh-proxy/en/ 

?lnk=1&url=https%

253A%252F%252Fworkspace.

fao.org%252Fsites

%252Fcodex%252FStandards

%252FCXS%2B70-1981%252FCXS_

070e.pdf. Accessed June 8, 2023. 

3. Official Methods of Analysis of AOAC 

INTERNATIONAL (2023. 22nd ed., 

AOAC INTERNATIONAL, Rockville, 

MD, Official Method 968.30. 

* 4. Fish and Shellfish; Amendments to the 

Canned Tuna Standard of Identity and 

Standard of Fill of Container, Docket No. 

FDA–2016–P–0147, Preliminary 

Regulatory Impact Analysis, Initial 

Regulatory Flexibility Analysis, 

Unfunded Mandates Reform Act 

Analysis. https://www.fda.gov/aboutfda/reports/economic-impact-analysesfda-regulations. 

List of Subjects in 21 CFR Part 161 

Food grades and standards, Frozen 

foods, Incorporation by reference, 

Seafood. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, the FDA proposes 

that 21 CFR part 161 be amended as 

follows: 

PART 161—FISH AND SHELLFISH 

■ 1. The authority citation for part 161 

continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 343, 348, 

371, 379e. 

■ 2. In § 161.190: 

■ a. Revise paragraph (a)(1); 

■ b. Add a heading to paragraph (a)(2); 

■ c. Revise paragraph (a)(3); 

■ d. Add a heading to paragraph (a)(4); 

■ e. Revise paragraphs (a)(5) through (7); 

■ f. Add a heading to paragraph (a)(8); 

■ g. Revise paragraphs (a)(8)(i), (iii), and 

(v) through (ix); 

■ h. Add paragraph (a)(8)(x); 

■ i. Revise paragraph (c); and 

■ j. Add paragraph (d). 

The revisions and additions read as 

follows: 

§ 161.190 Canned tuna. 

(a) * * * 

(1) Description. Canned tuna is the 

food consisting of processed fish of the 

species listed in paragraph (a)(2) of this 

section, prepared in one of the optional 

forms of pack specified in paragraph 

(a)(3) of this section, conforming to one 

of the color designations specified in 

paragraph (a)(4) of this section, may be 

in one or more of the optional packing 

media specified in paragraph (a)(5) of 

this section, and may contain one or 

more of the safe and suitable optional 

ingredients specified in paragraph (a)(6) 

of this section. It is packed in 

hermetically sealed containers and 

processed by heat to prevent spoilage. It 

is labeled per paragraph (a)(8) of this 

section. 

(2) Species. * * * 

(3) Forms of pack. The optional forms 

of processed tuna consist of loins and 

other striated muscular tissue of the 

fish. The loin is the longitudinal quarter 

of the great lateral muscle freed from 

skin, scales, visible blood clots, bones, 

gills, viscera and from the nonstriated 

part of the muscle, which part (known 

anatomically as the median superficial 

muscle) is highly vascular in structure, 

dark in color because of the retained 

blood, and granular in form. Canned 

tuna is prepared in one of the following 

forms of pack, determined following the 

methods prescribed in paragraph (c)(2) 

of this section. 

(i) Solid or solid pack consists of loins 

freed from any surface tissue discolored 

by diffused hemolyzed blood, cut in 

transverse segments to which no free 

fragments are added. In containers of 1 

pound or less of net contents, the 

segments are cut in lengths suitable for 

packing in one layer. In containers of 

more than 1 pound net contents, such 

segments may be cut in lengths suitable 

for packing in one or more layers of 

equal thickness. Segments are placed in 

the container with the planes of their 

transverse cut ends parallel to the ends 

of the container. A piece of a segment 

may be added if necessary to fill a 

container. The proportion of free flakes 

broken from loins in the canning 

process must not exceed 18 percent. 

(ii) Chunk, chunks, chunk style 

consists of a mixture of pieces of tuna 

in which the original muscle structure 

is retained. The pieces may vary in size, 

but not less than 50 percent of the 

drained weight of the contents of the 

container is retained on a 1⁄2-inch (or 

12.5-millimeter) mesh sieve. 

(iii) Flake or flakes consist of a 

mixture of pieces of tuna in which more 

than 50 percent of the drained weight of 

the contents of the container will pass 

through a 1⁄2-inch (or 12.5-millimeter) 

mesh sieve, but in which the muscular 

structure of the flesh is retained. 

(iv) Grated consists of a mixture of 

particles of tuna that have been reduced 

to uniform size, that will pass through 

a 1⁄2-inch (or 12.5-millimeter) mesh 

sieve, and in which the particles are 

discrete and do not comprise a paste. 

(v) Any of the specified forms of pack 

of canned tuna may be smoked. Canned 

smoked tuna must be labeled per 

paragraph (a)(8)(v) of this section. 

(4) Colors of pack. * * * 


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(5) Optional packing media. Canned 

tuna may be in one or more of the 

following optional packing media: 

(i) Any edible vegetable oil other than 

olive oil, or any mixture of such oils not 

containing olive oil; 

(ii) Olive oil; or 

(iii) Water. 

(6) Optional ingredients. One or more 

of the following safe and suitable 

optional ingredients may be used: 

(i) Salt. 

(ii) Flavorings and spices in 

accordance with § 101.22 of this 

chapter. 

(iii) Vegetable broth added in an 

aqueous solution, such that the dry 

weight of the vegetable extractives in 

the broth must not be more than 2.5 

percent of the labeled net weight of the 

container. The vegetable broth must be 

prepared from two or more of the 

following vegetables: Beans, cabbage, 

carrots, celery, garlic, onions, parsley, 

peas, potatoes, green bell peppers, red 

bell peppers, spinach, and tomatoes. 

(iv) Edible vegetable oil, excluding 

olive oil. The amount of edible 

vegetable oil must not exceed 5 percent 

of the volume capacity of the container, 

with or without any suitable form of 

emulsifying and suspending ingredients 

that are generally recognized as safe per 

§ 170.30 of this chapter or approved as 

a food additive to aid in dispersion of 

the oil, as seasoning in canned tuna 

packed in water. 

(v) Sodium acid pyrophosphate added 

for the purpose of inhibiting the 

development of struvite crystals. 

Sodium acid pyrophosphate may be 

added in a quantity that must not 

exceed 0.5 percent by weight of the 

finished food. 

(7) Method of color determination. For 

the color designations specified in 

paragraph (a)(4) of this section, the 

following method must be used: 

Recombine the separations of drained 

product resulting from the method 

prescribed in paragraph (c)(2) of this 

section. Pass the combined portions 

through a 1⁄4-inch (or 6.3-millimeter) 

sieve complying with the specifications 

set forth in ‘‘Official Methods of AOAC 

INTERNATIONAL,’’ 22nd Ed. (2023), 

Table 1, ‘‘Nominal Dimensions of 

Standard Test Sieves (U.S.A. Standard 

Series),’’ under the heading ‘‘Definitions 

of Terms and Explanatory Notes,’’ 

(incorporated by reference, see 

paragraph (d) of this section). Mix the 

sieved material and place a sufficient 

quantity into a 307 × 113 size container 

(bearing a top seam and having a false 

bottom approximately 1⁄2-inch (or 1.3- 

centimeter) deep and painted flat black 

inside and outside) so that after tamping 

and smoothing the surface of the sample 

the material will be 1⁄8-inch (or 0.3- 

centimeter) to 1⁄4-inch (or 0.6- 

centimeter) below the top of the 

container. Within 10 minutes after 

draining through the 1⁄4-inch (or 6.3- 

millimeter) sieve, determine the 

Munsell value of sample surface. 

(i) Determine the Munsell value of the 

sample. The standards with which 

comparisons are made are essentially 

neutral matte-finish standards, 

equivalent in luminous reflectance of 

light at a wavelength of 555 nanometers 

and 33.7 percent of the luminous 

reflectance of magnesium oxide (for 

Munsell value 6.3); 22.6 percent of the 

luminous reflectance of magnesium 

oxide (for Munsell value 5.3). When 

examining albacore designated as 

‘‘white’’, conduct the procedure using 

standards of Munsell value 6.3. 

(ii) For blended tuna, vary the method 

by first separating the tuna flakes into 

the different colors before passing them 

through the 1⁄4-inch (or 6.3-millimeter) 

sieve, then determining the color value 

of each portion separately. If necessary, 

use a sample container with a false 

bottom greater than 1⁄2 -inch (or 1.3 

centimeter) deep. 

(8) Labeling. (i) The specified name of 

the canned tuna described in this 

section, except for tuna packed in water 

or tuna that is smoked, is formed by 

combining the designation of form of 

pack with the color designation of the 

tuna; for example, ‘‘Solid pack white 

tuna’’, ‘‘Grated dark tuna’’, etc. For 

blended tuna, use both applicable color 

designations of the blended flakes with 

the predominant portion of the 

container first; for example, ‘‘Blended 

white and dark tuna flakes’’, ‘‘Blended 

dark and light tuna flakes’’. 

* * * * * 

(iii) For canned tuna packed in 

vegetable oil or olive oil, the label must 

include the name of any optional 

packing medium used, as specified in 

paragraph (a)(5) of this section, 

preceded by the word ‘‘in’’ or the words 

‘‘packed in’’. If the tuna is packed in an 

optional vegetable oil, as specified in 

paragraph (a)(5)(i) of this section, the 

name or names of the oil or the general 

term ‘‘vegetable oil’’ may be used. 

* * * * * 

(v) If any of the specified forms of 

canned tuna are smoked, the word 

‘‘smoked’’ must appear as a part of the 

name on the label, for example, 

‘‘Smoked light tuna flakes’’. 

(vi) If the canned tuna contains one or 

more of the optional ingredients in 

paragraph (a)(6)(ii) through (iv) of this 

section, the label must appropriately 

declare the ingredients by the common 

or usual name in accordance with 

§ 101.22 of this chapter. If the 

ingredients designated in paragraph 

(a)(6)(iii) of this section are used, the 

term ‘‘vegetable broth’’ must be 

declared. 

(vii) If the canned tuna contains the 

optional ingredient sodium acid 

pyrophosphate as provided in paragraph 

(a)(6)(v) of this section, the label must 

bear the statement ‘‘pyrophosphate 

added’’ or ‘‘with added pyrophosphate’’. 

(viii) Wherever the name of the food 

appears on the label so conspicuously as 

to be easily seen under customary 

conditions of purchase, the names of the 

optional ingredients used, as specified 

in paragraphs (a)(8)(iii), (vi), and (vii) of 

this section, must immediately and 

conspicuously precede or follow such 

name without intervening, written, 

printed, or graphic matter except that 

the common name of the species of tuna 

fish may so intervene, but the species 

name ‘‘albacore’’ may be used only for 

canned tuna of that species which meets 

the color designation ‘‘white’’ as 

prescribed by paragraph (a)(4)(i) of this 

section. 

(ix) Statements of optional ingredients 

present required by paragraph (a)(8)(vi) 

of this section, but not subject to the 

provisions of paragraph (a)(8)(viii) of 

this section, must be included on the 

label with such prominence and 

conspicuousness as to render them 

likely to be read and understood by the 

ordinary individual under customary 

conditions of purchase. 

(x) Each of the ingredients used in the 

food must be declared on the label as 

required by the applicable sections of 

parts 101 and 130 of this chapter. 

* * * * * 

(c) Fill of container. (1) The standard 

of fill of container for canned tuna is a 

fill such that tuna must constitute at 

least 72 percent of the fill of the 

container. The general method for 

determining the fill of containers is 

specified in § 130.12(b) of this chapter. 

The drained weight method, as 

specified in paragraph (c)(2) of this 

section, must be used to verify the 

standard fill of container for canned 

tuna products. The drained weight of 

each container must be determined 

individually, and an average value must 

be determined based on an average 

taken from a minimum of 24 containers. 

(2) Determine the drained weight of 

the tuna using unopened canned tuna 

containers left at 75 ± 5°F (or 24 ± 3 °C) 

for at least 12 hours immediately before 

testing. Empty the contents of one 

individual tuna container onto a 

previously weighed sieve and evenly 

distribute the contents across the bottom 

of the sieve. Without shifting any tuna, 


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tilt the sieve at a 17- to 20-degree angle 

to help facilitate drainage. Allow the 

tuna to drain for 2 minutes, starting 

when the product is applied to the 

sieve. The sieve containing the drained 

tuna is then reweighed, after excess 

packing media is gently removed from 

the bottom of the sieve with a paper 

towel. The drained weight is calculated 

by subtracting the difference in the 

weights as follows: 

Final weight of sieve with tuna—Empty 

weight of sieve = Drained weight of 

tuna 

If the contents of the tuna container 

weigh less than 3 pounds (1.36 

kilograms), then a sieve with an 8-inch 

(20-centimeter) diameter must be used. 

If the contents of the tuna container 

weigh 3 pounds (1.36 kilograms) or 

more, then a sieve with a 12-inch (30- 

centimeter) diameter must be used. The 

bottom of the sieve has a woven-wire 

cloth mesh complying with the 

specifications set forth for the 2.80 mm 

(No. 7) sieve in the ‘‘Official Methods of 

AOAC INTERNATIONAL,’’ 22nd Ed. 

(2023), Table 1, ‘‘Nominal Dimensions 

of Standard Test Sieves (U.S.A. 

Standard Series),’’ under the heading 

‘‘Definitions of Terms and Explanatory 

Notes,’’ (incorporated by reference, see 

paragraph (d) of this section). 

(i) Determination of free flakes: If the 

optional form of tuna ingredient is solid 

pack, determine the percent of free 

flakes. Any flakes resulting from the 

drained weight procedure described in 

paragraph (c)(2) of this section are to be 

weighed as free flakes. Only fragments 

that were broken in the canning process 

are considered to be free flakes. Using 

a spatula, scrape free flakes gently from 

the outside of the drained tuna product. 

Weigh the aggregate free flakes that were 

broken from the loin segments in the 

canning process and calculate their 

percentage of the total drained weight. 

(ii) Determination of particle size: If 

the optional form of tuna ingredient is 

chunks, flakes, or grated, the drained 

tuna product resulting from the drained 

weight procedure described in 

paragraph (c)(2) of this section, is gently 

separated by hand, care being taken to 

avoid breaking the pieces. The separated 

pieces are evenly distributed over the 

top sieve of the screen separation 

equipment described in paragraph 

(c)(2)(iii) of this section. Beginning with 

the top sieve, lift and drop each sieve by 

its open edge three times. Each time, the 

open edge of the sieve is lifted the full 

distance permitted by the device. 

Combine and weigh the material 

remaining on the top three sieves (11⁄4- 

inch (or 37.5-millimeter), 1-inch (or 

25.0-millimeter), 1⁄2-inch (or 12.5- 

millimeter) meshes) and determine the 

combined percentage retention by 

weight in relation to the total drained 

weight. 

(iii) The sieving device referred to in 

paragraph (c)(2)(ii) of this section 

consists of three sieves, each 

approximately 1 foot square, loosely 

mounted, one above another, in a metal 

frame. The mesh in the top sieve 

complies with the specifications for 1 

1⁄4-inch (or 37.5-millimeter) woven-wire 

cloth mesh as prescribed in paragraph 

(a)(7) of this section. The meshes in the 

sieve below comply with similar 

specifications for 1-inch (or 25.0- 

millimeter) and 1⁄4-inch (or 12.5- 

millimeter) mesh as set forth in AOAC 

Official Methods, Table 1, ‘‘Nominal 

Dimensions of Standard Test Sieves 

(U.S.A. Standard Series)’’ (incorporated 

by reference, see paragraph (d) of this 

section). The sides of each sieve are 

formed, in a raised rim, from 3⁄4-inch (or 

1.9-centimeters) × 1⁄8-inch (or 0.3- 

centimeter) metal strap. The frame has 

tracks made of 3⁄8-inch (or 1.0- 

centimeter) angle metal to support each 

sieve under each side. The tracks are 

positioned to permit each sieve a free 

vertical travel of 13⁄4-inches (or 4.4- 

centimeters). 

(3) If canned tuna falls below the 

applicable standard of fill of container 

prescribed in paragraph (c)(1) of this 

section, the label must bear the general 

statement of substandard fill per 

§ 130.14(b) of this chapter. 

(d) Incorporation by reference. Table 

1, Nominal Dimensions of Standard Test 

Sieves (U.S.A. Standard Series), 

Definitions of Terms and Explanatory 

Notes, Official Methods of Analysis of 

AOAC INTERNATIONAL, 22nd Ed., 

2023 is incorporated by reference into 

this section with the approval of the 

Director of the Federal Register under 5 

U.S.C. 552(a) and 1 CFR part 51. This 

incorporation by reference (IBR) 

material is available for inspection at 

the Food and Drug Administration 

(FDA) and at the National Archives and 

Records Administration (NARA). 

Contact FDA’s Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

For information on the availability of 

this material at NARA, visit 

www.archives.gov/federal-register/cfr/ 

ibr-locations.html or email 

fr.inspection@nara.gov. The material 

may be obtained from AOAC 

INTERNATIONAL, 2275 Research 

Blvd., Suite 300, Rockville, MD 20850– 

3250; 1–800–379–2622. 

Dated: August 14, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2023–17916 Filed 8–24–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Federal Bureau of Investigation 

28 CFR Part 105 

[Docket No. FBI–154; AG Order No. 5736– 

2023] 

RIN 1110–AA33 

Child Protection Improvements Act 

Criteria for Designated Entity 

Determinations 

AGENCY: Federal Bureau of 

Investigation, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Department of Justice is 

proposing to promulgate regulations 

(‘‘proposed rule’’ or ‘‘rule’’) concerning 

the Child Protection Improvements Act 

of 2018 (‘‘CPIA’’). The CPIA provides a 

means by which authorized qualified 

entities can have access to national 

criminal history background checks for 

determinations of whether covered 

individuals have been convicted of, or 

are under pending indictment for, a 

crime that bears upon their fitness to 

have responsibility for the safety and 

well-being of children, the elderly, or 

individuals with disabilities. As 

required by the CPIA, these proposed 

regulations would establish the criteria 

to be utilized by an entity designated by 

the Federal Bureau of Investigation (FBI) 

to make these determinations. 

DATES: Written comments must be 

postmarked and electronic comments 

must be submitted on or before 

September 25, 2023. Commenters 

should be aware that the electronic 

Federal Docket Management System 

will not accept comments after 11:59 

p.m. eastern time on the last day of the 

comment period. 

ADDRESSES: You may review this 

proposed rule on https://

www.regulations.gov and use the 

electronic comment form for these 

regulations to submit your comments. 

Submit written comments by U.S. Postal 

Service or other commercial delivery 

services, addressing them to FBI, CPIA 

Comments, Attention, Betsy C. Taylor, 

Office of the General Counsel (OGC), 

FBI Criminal Justice Information 

Services (CJIS) Division, 1000 Custer 

Hollow Road, Module C3, Clarksburg, 

West Virginia 26306. 


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